Thursday, January 24, 2013

Plavix Plaintiffs’ Counts Continue To Drop

This post is really the work of co-blogger Eric Alexander, but technical problems meant that Bexis had to post it.

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On this week of Martin Luther King Day and the Presidential Inauguration, we start this post with some regrets. We regret that we lack the eloquence to offer a sufficiently meaningful link between the cases we discuss and the inspiration that Dr. King has provided to so many, even after his brutally untimely death.  We regret that any homage we pay to our nation and its democracy might come across as fluff.  In our day job, we are happy to take on tough cases, depositions, motions, whatever.  Here, the wiser choice seems to be to decline the challenge of trying to establish a link.  We might offer the familiar quote that “Injustice anywhere is a threat to justice everywhere.  We are caught in an inescapable network of mutuality, tied in a single garment of destiny.  Whatever affects one directly, affects all indirectly” and argue that justice to manufacturers of drugs and devices in the courts of our nation is included.  Nah.  We like when courts get the law right and hold plaintiffs to their proof. We decry when courts tilt the table for whatever reason. We will not, however, cheapen the real struggles in the country or the importance of our democratic ideals usually winning out by making comparisons to the cases we are discussing. At least not this week. We make no promises for the next post.  We might just hum “Abraham, Martin and John” or “Renegades of Funk” as we type.    

            We do not regret the decisions in Begley v. Bristol-Myers Squibb Co., No. 06-6051 (FLW), 2103 US. Dist. LEXIS 4849 (D.N.J. Jan. 11, 2013), and LaBarre v. Bristol-Myers Squibb Co., No. 06-6050 (FLW) (D.N.J. Jan. 11, 2013), each granting summary judgments on all claims in cases alleging bleeding from Plavix based principally on lack of evidence that the warning was inadequate as to bleeding.  If this sounds familiar, it should.  Two weeks ago, we posted on the Solomon decision from the same judge. So, why are we posting on more of the same?  Well, Solomon applied Texas law, while Begley applied Illinois law and LaBarre applied Florida law.  Also, the decisions brushed aside some different arguments from the various plaintiffs, even though they were represented by the same firm and relying on the same expert—we will get to them later.  Why are we justifying ourselves?  Read or read not.  There is no why.  (A little pre-CGI Yoda.)

            As would be expected, each decision is well thought out and systematic.  We particularly appreciate the restraint shown in each for a federal court to resist making new state law.  We also appreciate the efficiency in each of denying a “negligence claim [that] is nothing more than a restatement of her defective design, defective manufacturing, and failure-to-warn claims” and in denying Rule 56(d) requests for more discovery on subjects that are “neither relevant nor probative Plaintiff’s claims.”  Particularly on the former point, we have seen some courts take a claim for “negligence” in a drug case as encompassing any conduct that can be criticized; the more sensible view is that negligence claims are still really claims based on warnings, design, or manufacturing, but requiring additional proof beyond strict liability.  For instance, that the Defendant was negligent in failing to provide inadequate warnings.  We also enjoyed the clear rejection that arguments as to the efficacy of the product have anything to do with whether the warnings were adequate, at least under Illinois and Florida law.  There may be claims in some states based on overstating the efficacy of a drug, but failure to warn claims in Illinois and Florida are about “the product’s known dangerous propensities” and “any danger or harm that may result from ingesting the drug,” respectively.  Begley, *17; LaBarre, *22.  We also liked the simple recognition that the adoption of Comment k in Illinois and Florida meant that the design defect claims fell with the lack of proof of inadequate warnings and that a manufacturing defect claim fails when there is no allegation that the plaintiff’s drug “deviated from the construction or specifications of Plavix.”  Begley, **27-28; LaBarre, **32-34.

            This brings us to the meat of the decisions, which was whether there was evidence to raise a genuine issue of material fact as to the adequacy of the Plavix warnings for the risk of bleeding.  After recognizing that Illinois and Florida require expert testimony where there are allegations that the extensive warnings provided were not good enough, the court turned to what plaintiffs had to offer.  It is not clear why the plaintiff in Begley had more criticisms of the Plavix label than the plaintiff in LaBarre did or why the plaintiff in LaBarre also pointed to at least one company document to support her argument.  Our friends at the Miller firm, who represented these plaintiffs, surely know from many summary judgment decisions on warnings in diet drug cases in the Philadelphia Court of Common Pleas, if from nowhere else, that it is important to generate evidence of a failure to warn and an impact of that failure to warn on the prescriber’s decision to prescribe.  (Rumor has it that we once handed over a stipulation of dismissal to one of their lawyers in the middle of a deposition based on the expectation that they understood the consequence of not getting magic words. We cannot confirm or deny that rumor.)  Regardless, the real problem with plaintiff’s warnings case was that they relied on a single expert, our old friend, Lemuel Moye, M.D., Ph.D., to establish the inadequacy of warnings and he never articulated what different warnings as to a risk of bleeding should have said.  We are not sure if this came up, but Dr. Moye was on the Cardiovascular and Renal Drugs Advisory Committee when it recommended approval of Plavix in 1997 and he was the only one who voted against it.  Back then, he had concerns about proof of efficacy—not safety—so it is not surprising that his opinions as an expert in litigation over Plavix continued to focus on efficacy.  Since the court had already determined that risk of the injury that plaintiff suffered, not whether the drug works for its indication, is the focus, it was pretty easy to see that Dr. Moye’s opinions on the treatment of efficacy in the Plavix label went nowhere.  He did have some opinions about the risk of bleeding of the product, but never offered “how Plavix’s warning label should have reflected the duration of therapy and the impact of a long term therapy on the risk of increased bleeding.”  LaBarre, *28. 

            This begs the question why plaintiffs would get through expert discovery and summary judgment briefing without an expert who would say that the warning of the risk at issue should have been revised in a particular way to make it adequate.  At what point was it apparent that they could not find an expert who would actually say what is typically required to get by summary judgment?  We would expect that this shortcoming will cripple quite a few of these plaintiffs, at least if they only have Dr. Moye to carry the water.  While the court notes that it is proceeding with summary judgment motions one by one in these “related cases”—footnote 2 in each decision—there certainly will be a point where summary judgment on some or all these cases can be decided in one fell swoop.   In Begley, the court did not reach the issue of proof of proximate cause for a failure of warn, but, in LaBarre, it reached the issue as an additional ground for summary judgment.  A pretty easy conclusion where, as would be expected given the lack of warnings evidence, the prescribers “both represented that they would have not changed their prescription for Mr. LaBarre even understanding the additional risk or questions of efficacy Plaintiff has raised in this litigation.”  LaBarre, *32.  Of course, courts do like to limit the chance of successful appeal by offering alternative grounds, but every plaintiff is going to fail proximate cause for failure to warn when there is no failure to warn.  It seems like a lot of work for the court to keep writing detailed decisions when the common failings of plaintiffs’ proof should submarine a bunch of their cases. 

            If the court had really wanted to be efficient, though, these plaintiffs would not have been allowed to re-plead from New Jersey law to their home state law after “two separate decisions rendered by the New Jersey Supreme Court in 2007.”  Begley, *1 n.1; LaBarre, *1 n.1.  Presumably the cases were two of the ones discussed here  http://druganddevicelaw.blogspot.com/2008/06/ebb-and-flow-of-law-new-jersey-edition.html  and not miscites to the later powerful DeBoard and Bailey decisions that made New Jersey law less plaintiff-friendly.  Plaintiffs obviously picked New Jersey law when they filed back in 2006 because they thought it would give them a better shot than their home state law.  They had active complaints asserting New Jersey claims for three years before reversing field.  Without belaboring the standards for allowing plaintiffs to amend their complaints well after filing or many times, it does seem that the amendments here forestalled the inevitable summary judgment and just forced the court to issue separate decisions where a single ruling that no plaintiff could satisfy the requirements of the New Jersey Product Liability Act that they had pled was once possible.  We will take separate decisions when the end result is the same and just.

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